Fate Therapeutics will present clinical and preclinical data from its off-the-shelf cell therapy platform at the European Congress of Rheumatology (EULAR 2025). The oral presentation will focus on Phase 1 clinical trial data for FT819, a CD19-targeted CAR T-cell product candidate, in patients with moderate-to-severe systemic lupus erythematosus (SLE). The presentation will also include preclinical data on the company’s iPSC-derived CAR T-cell and CAR-NK cell platform across multiple autoimmune indications, emphasizing the potential of their “Sword and Shield” technology and multi-antigen targeting to eliminate the need for conditioning chemotherapy.
This research is particularly noteworthy due to the potential for an off-the-shelf, fludarabine-free CAR T-cell therapy for SLE. Current CAR T-cell therapies often require intense conditioning regimens, including fludarabine, which can have significant side effects. Successful development of a fludarabine-free approach could expand access to this promising therapy by reducing treatment-related toxicity and potentially enabling outpatient treatment, improving the patient experience and reducing healthcare costs.
The Phase 1 trial of FT819 is exploring a fludarabine-free conditioning regimen and a maintenance therapy arm without any conditioning. Preclinical data showcases the “Sword and Shield” technology and multi-antigen targeting strategies designed to improve treatment outcomes and pave the way for outpatient administration. The company also plans to present data on its iPSC-derived CAR-NK cell platform for autoimmune diseases.
This research could represent a significant step forward in the development of safer and more accessible cell therapies for autoimmune diseases. Positive results from the FT819 trial and further development of the iPSC platform could position Fate Therapeutics as a leader in the off-the-shelf cell therapy space, potentially transforming the treatment landscape for patients with SLE and other autoimmune conditions. The possibility of outpatient treatment could also disrupt the current model of care, offering significant advantages for patients and the healthcare system.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
